Job Summary:

• Perform regulatory requirement review.
• Prepare, validate and review Audit Calendar.
• Prepare and communicate Audit Mandate.
• Prepare and conduct audit opening and closing meetings.
• Prepare, validate and review Audit Questionnaire (including the determination of Audit Method and Sampling).
• Prepare Audit Checklists in accordance with Audit Questionnaires.
• Get access to supplementary information for audit execution
• Execute physical, desktop or interview audits.
• Collect acceptable audit evidence.
• Compile audit results and draw conclusions.
• Determine non-compliance severity level.
• Determine non-compliance occurrence level.
• Produce and review Audit Reports.
• Produce, record and communicate audit results via the CAR management database.
• Analyse Audit Program performance in accordance with determined KPI's.
• Produce Audit monthly review report.
• Analyse submitted Corrective Action Plan (CAP) to determine

Skills on Resume: 

• Regulatory Compliance Knowledge (Hard Skills)
• Audit Calendar Management (Hard Skills)
• Communication Skills (Soft Skills)
• Audit Methodology (Hard Skills)
• Documentation Skills (Hard Skills)
• Information Management (Hard Skills)
• Audit Execution (Hard Skills)
• Analytical Skills (Hard Skills)

Job Summary:

• Performing protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable Standard Operating Procedures (SOP's) and Good Laboratory Practice (GLP) regulatory requirements.
• Evaluating responses to Good Laboratory Practice (GLP) inspection reports and performing follow-up with respondents, management, or others, if needed, to ensure resolution.
• Ensuring that systems used in Good Laboratory Practice (GLP) quality assurance are properly maintained.
• Notifying management of service failures.
• Performing study sign-off including but not limited to quality assurance statement preparation (internal/external) and report finalisation.
• Performing Standard Operating Procedures (SOP's) reviews.
• Participating in internal facility and supplemental inspections, under supervision.
• Deliver basic quality/regulatory training, under supervision. 
• Identifying opportunities for process improvement and harmonisation efforts that promote best practices.
• Validate and follow CAR immediate contingency.
• Follow CAP implementation to determine if it is acceptable or not.
• Validate CAP effectiveness to determine if it is acceptable or not.
• Close CAR in CAR management database (including closing communication).
• Keep Audit Program evidence and records.

Skills on Resume: 

• Regulatory Compliance Knowledge (Hard Skills)
• Audit Skills (Hard Skills)
• Communication Skills (Soft Skills)
• Quality Assurance Management (Hard Skills)
• Documentation and Reporting (Hard Skills)
• Process Improvement (Hard Skills)
• Training Delivery (Soft Skills)
• Decision-making (Hard Skills)

Job Summary:

• Performs monthly audits of all aspects of Operations and provides technical support data analysis, reports, trends and recommendations.
• Participates in root cause analysis and creates action plans using established methodologies.
• Works on special targeted audits outside of the standard associate audits.
• Provides detailed audit results and analysis of error trends with the ultimate goal of improving the customer performance and accuracy in all operational areas.
• Proactively schedules and supports corporate special audits for root cause and fiduciary/expense avoidance situations. 
• Responsible for knowing external requirements including BCBSA guidelines (including but not limited to MTM and Blue Card), federal and state mandates, as well as account contractual requirements, including performance standards. 
• Conducts Root Cause and Frequency analysis to identify opportunities for improvement to systems and business processes. 
• Assists in the review and documentation of new procedures introduced to the auditing team.
• Pursue remediation through numerous channels including SBU operational areas, the TOS division, the Facets Benefits Team, Medical Management and the Special Investigations Unit.
• Perform all necessary follow-up activities related to audits errors to ensure that corrective action have been appropriately taken.
• Adheres to all departmental quality standards.
• Provides coaching and mentoring to audited customers on a monthly basis and is considered a go-to resource on SBU transactions.
• Serves as a subject matter expert for all previously mentioned operational areas by providing technical expertise regarding claims adjudication, customer service procedures, medical policies, auditing practices, etc. 
• Analyzes, clarifies and/or interprets complex customized/non-standard benefit requests, 

Skills on Resume: 

• Data Analysis (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Audit Expertise (Hard Skills)
• Knowledge of Regulations (Hard Skills)
• Process Improvement (Hard Skills)
• Documentation and Procedure Review (Hard Skills)
• Remediation and Follow-up (Hard Skills)
• Subject Matter Expertise (Hard Skills)

Job Summary:

• Provides information and decisions to operations (Sales, Business Analysts, Executive Inquiry, E&B Techs, etc.). 
• Coaching existing auditors in process improvement to gain efficiencies. 
• Reviews and analyzes MTM discrepancies in comparison to internal audit findings to better identify trends. 
• Participate in training within the SBU Quality Auditing Department with the goal of learning the Lead Auditor’s accountabilities.
• Identifies procedural, system and training issues based upon audit findings and initiates resolution to these problems through recommending alternate procedures/processes and developing and evaluating SOPs. 
• Evaluates the effectiveness of current processes/procedures, techniques, systems and associates and proposes solutions to improve results. 
• Conducts training & mentoring of new auditors and operational associates. 
• Serves as a resource in the creation of technical job improvement publications to be released to all operational areas and in some cases is the sole author.
• Participates on and/or leads projects, workgroups, including those from upper CareFirst management (Directors, Senior Directors and Vice Presidents).
• The Senior Auditor will assist in performing technical system and platform user acceptance testing while working with the OTS and TOS areas
• Testing that proposed system changes are working correctly and have no negative downstream affects to audit and operational processes. 
• Review and analysis of new and existing metric reports that are required for the day-to-day audit operations as well as ad-hoc analysis of specific identified issues.

Skills on Resume: 

• Analytical Skills (Hard Skills)
• Process Improvement (Hard Skills)
• Training and Mentoring (Soft Skills)
• SOP Development (Hard Skills)
• Problem-Solving Skills (Soft Skills)
• Project Management (Soft Skills)
• Technical Acumen (Hard Skills)
• Data Analysis and Reporting (Hard Skills)

Job Summary:

• Prepares and completes audit checklists and questionnaires utilizing the audit management software tool.
• Follows protocols and conducts station audits according to the program and audit plan.
• Communicates with the auditee and audit team.
• Coordinates opening and closing meetings.
• Prepares and presents audit reports and evaluates evidence.
• Raises non- conformities and checks the corrective action/actions plans.
• Records and reports findings and observations clearly.
• Collaborates with the Audit and Training teams and makes recommendations for program continuous improvements and enhancements.
• Hosts and attends meetings and training sessions with managers as audit follow up to assist and inform of compliance requirements, recommended actions or use of Pulse system.
• Conducts training/coaching and LMS user technical supportt
• Meets with customer/airline representatives when/directed for training or audit related issues.

Skills on Resume: 

• Audit Management Software (Hard Skills)
• Adherence to Protocols (Hard Skills)
• Communication Skills (Soft Skills)
• Meeting Coordination (Soft Skills)
• Report Preparation  (Hard Skills)
• Identifying Non-conformities (Hard Skills)
• Reporting (Hard Skills)
• Continuous Improvement (Soft Skills)

Job Summary:

• Generating, reviewing, processing, and maintaining project documents
• Reviewing technical drawings and test documents for Good Documentation Practices.
• Recording, releasing, and controlling paper and electronic documentation
• Learning and understanding Quality System requirements and applying that knowledge to programs
• Assisting with the creation and modification of quality-related plans
• Maintaining project databases
• Maintaining Design History Files and Device History Records
• Performing project and Quality System administrative duties
• Depending on additional availability beyond the assignments above, this role may also assist in the following.
• Submitting project purchases, receiving orders in a purchasing system, supporting material traceability
• Assisting with supplier qualifications
• Coordination of distribution activities.
• Assisting with internal audits

Skills on Resume: 

• Document Management (Hard Skills)
• Good Documentation Practices (Hard Skills)
• Document Control (Hard Skills)
• Quality Systems Knowledge (Hard Skills)
• Quality-related Plans (Hard Skills)
• Database Management (Hard Skills)
• Administrative Duties (Soft Skills)
• Purchasing Support (Hard Skills)
• Supplier Qualifications  (Hard Skills)
• Distribution Coordination  (Soft Skills)
• Internal Audits  (Soft Skills)

Job Summary:

• Maintain GXP audit program for external supplier audits.
• Perform GXP external audits per Pacira’s annual Master Audit Schedule.
• Prepare GXP external audit reports with details on audit scope and observations of non-compliance.
• Assist with regulatory inspections and partner audits.
• Conduct annual Mock Recalls for commercial products.
• Create and author Standard Operating Procedures (SOPs) to support GXP external audits.
• Recommend corrective and preventive actions as need to support compliance within the department.
• Manage and maintain the Quality Agreements.
• Manage and maintain the Supplier/Vendor Qualification Program
• Responsible for the completion of routine audits and monitoring activities for clinical trials including the review of case report forms, study files, study protocols, and internal processes.
• Assist with the development and implementation of audit plans aimed at monitoring the compliance of clinical trials to applicable regulations, policies, and procedures.
• Contribute in developing and utilizes research audit tools that assess the quality indicators.
• Identify areas of deficiency in quality and reports those to leadership and other appropriate personnel.
• Ensure that audit findings have been adequately reported, and contribute to the preparation, implementation, and follow-up of corrective action plans. 
• Assists research staff in maintaining FDA compliance.

Skills on Resume: 

Auditing Skills (Hard Skills)

• Regulatory Compliance Knowledge (Hard Skills)
• Report Writing (Hard Skills)
• SOP Development (Hard Skills)
• Quality Management (Hard Skills)
• Clinical Trial Oversight (Hard Skills)
• Problem Identification (Hard Skills)
• Communication n (Soft Skills)